NCT05364372

SMLI With Hispanic Cancer Survivors and Caregivers

Symptom Management and Lifestyle Intervention With Hispanic Cancer Survivors and Caregivers

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Fewer than 20% of Hispanic cancer survivors meet the American Cancer Society's (ACS) Guidelines on Nutrition and Physical Activity. Diagnosed at younger ages, later stages and with fewer resources (e.g., access to care), Hispanic cancer survivors are more likely to suffer from many symptoms, which linger long after they have completed treatment and may prevent them from leading a healthy life. Healthier lifestyle behaviors (such as diet and physical activity) would result in an immediate benefit of reduced symptoms and long-term benefit of improved health while lowering cancer risk. This randomized controlled trial tests an intervention that will help in lessening survivors' symptoms to improve adherence to the ACS guidelines for cancer prevention ultimately improving overall health.

Detailed description

In the proposed randomized controlled trial, the investigators will test the 12-week SMLI against an attention control condition in 107 dyads of Hispanic cancer survivors who have completed curative treatments within the past two years and their informal caregivers. A 12-week follow-up will determine the sustainability of the intervention. The primary outcome of this trial, vegetable and fruit intake in survivors (secondary in caregivers), will be measured at baseline, 13, and 25 weeks, using validated methods. Additional secondary and exploratory outcomes will add to the rigor of the trial and provide robust findings for future dissemination efforts. Specific Aim #1: Test the efficacy of the SMLI as compared to attention control among Hispanic female cancer survivors and their caregivers with respect to: 1. Increase in fruit and vegetable consumption (measured via self-reported 24-hour recall and objectively with carotenoid skin colorimetry) 2. Increase in physical activity (Metabolic Equivalents hours/week of moderate to vigorous physical activity measured by actigraphy) and decrease in symptom severity index Specific Aim #2: Determine the extent to which improvements in primary and secondary outcomes over weeks 13 and 25 are mediated by social support and self-efficacy.

Conditions

• Cancer Survivors
• Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Symptom assessment only	Dyads will receive 12 weekly phone calls to assess symptom management.
BEHAVIORAL	Symptom management and lifestyle intervention	Survivor and caregiver dyads will work together with a coach to establish diet and physical activity change SMART goals. Motivational interviewing based weekly coaching sessions will review symptom management and goal attainment and then enact strategies to modify goals to be more relevant and achievable.

Timeline

• Start date: 2022-08-25
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2022-05-06
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States